Exposure to scatter radiation and orthopedic issues related to years of wearing lead aprons during long EP procedures has led electrophysiologists to seek out new ways to reduce the need for angiographic X-ray.

Advancements in radiofrequency (RF) catheter ablation technology have been incremental over the past 30 years in efforts to improve safety, procedural efficiency and patient outcomes. While some newer technologies have gained a lot of attention in electrophysiology (EP) over the past several years, RF remains the solid frontline treatment.

Researchers explored five-year data from more than 1,800 patients with nonvalvular AFib who underwent LAAO with Abbott's Amulet or Boston Scientific's Watchman 2.5. 

Researchers developed several new AI models that could guide the management of patients with non-valvular atrial fibrillation. There is still some work to do in terms of accuracy, but they already appear to outperform the traditional risk scores being used today.

A team of pediatric specialists worked closely with representative from Medtronic to develop the new pacemakers. Overall, the tiny devices—approximately one-quarter the size of a traditional pacemaker—were found to be both safe and effective. They are still under development.

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

Kestra Medical Technologies, known for its wearable heart monitors and defibrillators, intends to sell 10 million common shares priced somewhere between $14 and $16 per share. 

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced.